The goal of this clinical trial is to evaluate whether a high-intensity loading dose of ergocalciferol (vitamin D2) can normalize blood vitamin D levels more rapidly and safely than standard weekly dosing in patients with newly diagnosed aggressive non-Hodgkin lymphoma. The study will also assess the safety of both dosing strategies. The main questions it aims to answer are: * Does a high-intensity loading dose of ergocalciferol lead to faster normalization of serum 25-hydroxyvitamin D levels compared with standard weekly dosing? * Are there differences in safety and adverse events between the two dosing strategies? Researchers will compare a high-intensity loading dose regimen of ergocalciferol with a standard weekly dosing regimen to determine differences in vitamin D normalization and safety outcomes. Participants will: * Be randomly assigned to receive either a high-intensity loading dose or a standard weekly dose of ergocalciferol (vitamin D2) * Receive standard first-line immunochemotherapy for aggressive non-Hodgkin lymphoma * Have blood tests to monitor vitamin D levels, calcium, phosphate, and safety parameters at scheduled visits * Be followed for treatment response, survival outcomes, and adverse events during and after therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
52
Dose and Schedule: * Loading phase: Ergocalciferol 20,000 IU orally once daily (1 capsule per dose), administered 1-2 hours before breakfast, for 7 consecutive days. * Intensified phase: Following the loading phase, ergocalciferol 20,000 IU orally three times per week (Monday, Wednesday, and Friday) for a total treatment duration of 6 weeks from the first dose. * Maintenance phase: After completion of the initial 6-week treatment period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment. * Maximum duration of vitamin D₂ administration: Up to 18 weeks from the first dose of ergocalciferol. Thereafter, vitamin D dosing may be adjusted at the discretion of the treating physician.
Dose and Schedule: * Standard phase: Ergocalciferol 20,000 IU orally three times per week (Monday, Wednesday, and Friday), administered as 1 capsule per dose, 1-2 hours before breakfast, for a total duration of 6 weeks from the first dose. * Maintenance phase: After completion of the 6-week standard dosing period, ergocalciferol 20,000 IU orally once weekly (Monday) until completion of lymphoma treatment. * Maximum duration of vitamin D₂ administration: Up to 18 weeks from the first dose of ergocalciferol. Thereafter, vitamin D dosing may be adjusted at the discretion of the treating physician.
Phramonkutklao Hospital
Bangkok, Thailand
Proportion of Participants Achieving Vitamin D Normalization by Day 21
Vitamin D normalization is defined as a serum 25-hydroxyvitamin D level ≥ 30 ng/mL. This outcome is assessed as a binary outcome (yes/no).
Time frame: Day 21 (± 3 days) after the first dose of study medication
Event-Free Survival (EFS)
Event-free survival is defined as the time from randomization to the first occurrence of disease progression, relapse after response, initiation of new lymphoma therapy, or death from any cause.
Time frame: Up to 3 years
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from randomization to the first documented disease progression according to the Lugano 2014 criteria or death from any cause, whichever occurs first.
Time frame: Up to 3 years
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Time frame: Up to 3 years
Best Overall Response (BOR)
Best overall response is defined as the best response achieved after completion of first-line immunochemotherapy, including complete response (CR) or partial response (PR), as assessed by PET-CT or CT scan according to the Lugano 2014 criteria.
Time frame: Through the completion of first-line immunochemotherapy, approximately 24 weeks
Change in Serum 25-Hydroxyvitamin D Level
Changes in serum 25-hydroxyvitamin D levels will be compared between study arms and summarized as absolute change and central tendency measures (mean or median).
Time frame: Day 21 (± 3 days), Day 42 (± 3 days), Day 63 (± 3 days), and Day 126 (± 3 days) (end of treatment)
Incidence of Grade ≥ 3 Infections
Incidence of infections graded ≥ 3 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0.
Time frame: From randomization through 30 days after the last dose of study treatment, approximately 22 weeks
Safety and Treatment-Related Toxicity
Safety and toxicity will be assessed based on the incidence of hypercalcemia, hypophosphatemia, and other adverse events, graded according to CTCAE version 6.0.
Time frame: From randomization through 30 days after the last dose of study treatment, approximately 22 weeks
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